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迈威生物(688062) - 北京植德(上海)律师事务所关于迈威(上海)生物科技股份有限公司2025年第三次临时股东大会的法律意见书
2025-12-25 09:45
北京植德(上海)律师事务所 关于迈威(上海)生物科技股份有限公司 2025 年第三次临时股东大会的 法律意见书 植德沪(会)字[2025]0058 号 二〇二五年十二月 上海市徐汇区虹桥路 183 号徐家汇中心三期 A 座办公楼 27 层(THREE itc) 邮编:200030 27th Floor Tower A, THREE itc, No.183 Hongqiao Road, Xuhui District, Shanghai 200030 P.R.C 电话(Tel):021-52533500 传真(Fax):021-52533599 www.meritsandtree.com 北京植德(上海)律师事务所 关于迈威(上海)生物科技股份有限公司 2025 年第三次临时股东大会的 法律意见书 植德沪(会)字[2025]0058 号 致:迈威(上海)生物科技股份有限公司(贵公司) 本所律师参加本次会议进行见证,并根据《中华人民共和国公司法》(以下 简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证券法》")、 《上市公司股东会规则》(以下简称"《股东会规则》")、《律师事务所从事 证券法律业务管理 ...
迈威生物12月24日获融资买入1618.17万元,融资余额5.52亿元
Xin Lang Cai Jing· 2025-12-25 01:38
Group 1 - The core viewpoint of the news is that Maiwei Biotechnology has shown significant trading activity and financial performance, with a notable increase in revenue and changes in shareholder composition [1][2]. Group 2 - On December 24, Maiwei Biotechnology's stock rose by 0.99%, with a trading volume of 214 million yuan. The financing buy-in amount was 16.18 million yuan, while the financing repayment was 13.98 million yuan, resulting in a net financing buy-in of 2.20 million yuan. The total financing and securities balance reached 552 million yuan [1]. - The financing balance of Maiwei Biotechnology is 552 million yuan, accounting for 6.79% of its market capitalization, which is above the 60th percentile level over the past year, indicating a high level of financing [1]. - On the same day, the company had no shares repaid in securities lending, with 200 shares sold, amounting to 7,968 yuan. The securities lending balance was 325,600 yuan, which is below the 30th percentile level over the past year, indicating a low level of securities lending [1]. - As of September 30, the number of shareholders of Maiwei Biotechnology was 19,600, an increase of 9.15% from the previous period. The average circulating shares per person decreased by 8.38% to 10,425 shares [2]. - For the period from January to September 2025, Maiwei Biotechnology achieved operating revenue of 566 million yuan, a year-on-year increase of 301.03%. However, the net profit attributable to the parent company was -598 million yuan, reflecting a year-on-year increase of 13.89% [2]. - Among the top ten circulating shareholders as of September 30, 2025, E Fund Medical Healthcare Industry Mixed A ranked as the fourth largest shareholder with 3.17 million shares, marking a new entry. Hong Kong Central Clearing Limited ranked sixth with 2.87 million shares, a decrease of 1.87 million shares from the previous period. Southern CSI 1000 ETF ranked ninth with 2.19 million shares, also a new entry [2].
迈威生物9MW1911注射液临床试验申请获得美国FDA许可
Bei Jing Shang Bao· 2025-12-23 14:08
Core Viewpoint - Maiwei Biotech announced that it received a Clinical Study Continuation Notification from the FDA, allowing the clinical research of 9MW1911 to proceed as planned, focusing on its pharmacokinetics, safety, tolerability, and preliminary efficacy in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) participants [1] Group 1 - The FDA has approved the continuation of the clinical study for 9MW1911, which is a randomized, double-blind, placebo-controlled Phase IIa clinical trial [1] - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform, classified as a Class I therapeutic biological product [1] - The drug targets the ST2 receptor to block the IL33/ST2 signaling pathway and is currently advancing rapidly in Phase II clinical research in China, having completed the Phase IIa clinical study in COPD patients [1]
迈威生物(688062.SH):已实际回购4999.45万元公司股份
Ge Long Hui A P P· 2025-12-23 13:02
Core Viewpoint - Maiwei Biotech (688062.SH) has completed a share buyback, acquiring a total of 1,192,369 shares, which represents 0.30% of the company's total share capital [1] Summary by Categories Share Buyback Details - The maximum buyback price was 58.02 CNY per share, while the minimum price was 37.48 CNY per share [1] - The average buyback price was 41.93 CNY per share [1] - The total amount of funds used for the buyback was 49.9945 million CNY, excluding transaction fees such as stamp duty and commission [1]
迈威生物:9MW1911注射液临床试验申请获FDA许可
Core Viewpoint - Maiwei Biotech (688062) has received FDA approval for its clinical trial application for 9MW1911 injection, allowing the company to proceed with a Phase IIa clinical study to evaluate the pharmacokinetics, safety, tolerability, and preliminary efficacy of 9MW1911 in participants with moderate to severe chronic obstructive pulmonary disease (COPD) [1] Group 1 - The FDA issued a "Notice of Continuation of Clinical Research" for Maiwei Biotech on December 23 [1] - The clinical study will be randomized, double-blind, and placebo-controlled [1] - The focus of the study is on participants with moderate to severe COPD [1]
迈威生物:9MW1911注射液临床试验申请获得FDA许可
Zhi Tong Cai Jing· 2025-12-23 12:57
Core Viewpoint - Maiwei Biotech (688062.SH) has received a Study May Proceed Notification from the FDA, allowing the clinical trial application for 9MW1911 to proceed [1] Group 1: Company Information - 9MW1911 is an innovative monoclonal antibody developed based on a high-efficiency B lymphocyte screening platform [1] - The product is classified as a Class 1 therapeutic biological product [1] - 9MW1911 has a high affinity for the ST2 receptor, which blocks the IL33/ST2 signaling pathway [1]
迈威生物(688062.SH):9MW1911注射液临床试验申请获得FDA许可
智通财经网· 2025-12-23 12:56
9MW1911为一款基于高效B淋巴细胞筛选平台自主研发的创新单克隆抗体,属于治疗用生物制品1类, 可高亲和力结合ST2受体,从而阻断IL33/ST2 信号通路。 智通财经APP讯,迈威生物(688062.SH)发布公告,近日,公司收到美国食品药品监督管理局(FDA)签发 的《临床研究继续进行通知书》(Study May Proceed Notification),9MW1911注射液临床试验申请正式获 得FDA许可。 ...
迈威生物(688062) - 迈威生物自愿披露关于9MW1911注射液临床试验申请获得FDA许可的公告
2025-12-23 12:46
证券代码:688062 证券简称:迈威生物 公告编号:2025-077 迈威(上海)生物科技股份有限公司 自愿披露关于 9MW1911 注射液临床试验申请 获得 FDA 许可的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 近日,迈威(上海)生物科技股份有限公司(以下简称"迈威生物"或"公 司")收到美国食品药品监督管理局(FDA)签发的《临床研究继续进行通知书》 (Study May Proceed Notification),9MW1911 注射液临床试验申请正式获得 FDA 许可。由于药品的研发周期长、审批环节多,容易受到一些不确定性因素的影响, 敬请广大投资者谨慎决策,注意防范投资风险。现将相关情况公告如下: 一、药品基本情况 药品名称:9MW1911 注射液 申请号:IND 177824 申请人:迈威(上海)生物科技股份有限公司 审批结论:FDA 已完成对本次申请的安全性评估,同意本品按照拟定的临床 研究计划开展,即"以评估 9MW1911 在中重度慢性阻塞性肺疾病(COPD)参与 者中的药 ...
迈威生物:累计回购约119万股
Mei Ri Jing Ji Xin Wen· 2025-12-23 12:38
2024年1至12月份,迈威生物的营业收入构成为:医药制造行业占比99.92%,其他业务占比0.08%。 每经AI快讯,迈威生物(SH 688062,收盘价:39.45元)12月23日晚间发布公告称,2025年12月23日, 公司完成回购,已实际回购公司股份约119万股,占公司总股本的比例为0.3%,回购最高价格为58.02 元/股,回购最低价格为37.48元/股,回购均价为41.93元/股,支付的资金总额为人民币4999.45万元。 每经头条(nbdtoutiao)——地产"优等生"受困20亿元到期债务,首次债务展期仍在博弈,明年还有超 百亿元公开债到期 (记者 王晓波) 截至发稿,迈威生物市值为158亿元。 ...
迈威生物(688062) - 迈威生物关于股份回购实施结果的公告
2025-12-23 12:33
迈威(上海)生物科技股份有限公司 关于股份回购实施结果的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 证券代码:688062 证券简称:迈威生物 公告编号:2025-078 重要内容提示: | 回购方案首次披露日 | 2025/6/27 | | | | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 6 月 26 日~2026 6 月 | 年 | 25 日 | | 预计回购金额 | 2,500万元~5,000万元 | | | | 回购价格上限 | 66.46元/股 | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | | | □用于转换公司可转债 | | | | | □为维护公司价值及股东权益 | | | | 实际回购股数 | 119.24万股 | | | | 实际回购股数占总股本比例 | 0.30% | | | | 实际回购金额 | 4,999.45万元 | | | | 实际回购价格区间 | 37.48元/股~58.02元/股 | | | 一、 ...